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<div class="solution-detail contact">
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            <h3>GMP质量和药政管理:</h3>
            泰亨的质量及药政管理专家们拥有经年的GMP审计、注册管理和政策法规咨询经验，能为客户提供高效可行的质量管理及药品注册服务。<br><br>
            <div class="fl" style="margin-right:250px;">
                <b style="color:#70bded;font-size:16px;">药品注册</b><br>
                <b>·</b>  US ANDA申请；<br>
                <b>·</b>  US IND/NDA申报支持；<br>
                <b>·</b>  US EDMF文件及其变更资料的制作与递交；<br>
                <b>·</b>  US申报资料的缺陷信回复支持；<br>
                <b>·</b>  欧盟CEP申请；<br>
                <b>·</b>  eCTD格式转换；<br>
                <b>·</b>  US FDA工厂注册、自认定与NDC登记；<br>
                <b>·</b>  药品注册的策略支持；<br>
                <b>·</b>  进口/国产药品注册的可行性评估和指导完善；<br>
                <b>·</b>  进口/国产药品注册资料的制作和提交（含翻译）；<br>
                <b>·</b>  仿制药质量一致性评价注册。
            </div>
            <div class="fl">
                <b style="color:#70bded;font-size:16px;">质量管理</b><br>
                <b>·</b>  合同生产商审计；<br>
                <b>·</b>  合同实验室审计；<br>
                <b>·</b>  供应商审计；<br>
                <b>·</b>  FDA审计支持；<br>
                <b>·</b>  体系辅导；<br>
                <b>·</b>  模拟审计；<br>
                <b>·</b>  验证审核
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<?php require $this->__RAD__ . 'include/footer.php';?>
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